PH FDA to soon clear Pfizer COVID-19 vaccine for those aged 12 to 15 yrs old

MB – Published May 27, 2021, 1:32 AM

Those between 12 to 15 years old may soon be vaccinated against the coronavirus disease (COVID-19) in the Philippines.

This, after the American drug maker Pfizer applied for an amendment to its emergency use authorization (EUA) to include children aged 12 to 15 years old, who will be allowed to receive the vaccine, said Food and Drug Administration (FDA) Director-General Rolando Enrique Domingo. 

“Yung Pfizer-BioNTech, yung pinaka una natin na binigyan ng EUA na vaccine, last week May 20, they applied for an amendment to include 12 to 15 year olds doon sa pwedeng gamitan ng bakuna (The Pfizer-BioNTech, the first to be granted an EUA here, has applied for an amendment to include 12 to 15 years old in those who can use the vaccine),” he said during the Cabinet meeting on Wednesday night, May 26.  

“Early this evening I already got the recommendations of our experts and it’s very favorable. So within the week, we will be issuing an amendment to the emergency use authorization of Pfizer and we will be able to use it in children 12 to 15 year old,” added Domingo. 

The United States government earlier authorized the use of Pfizer-BioNTech COVID-19 vaccine on children aged 12 to 15 years old, according to Domingo. 

“So pag dumating po yung maraming inorder ni Secretary Charlie (Carlito Galvez) na mga Pfizer, maari na po itong gamitin sa mga batang 12 to 15 year old (So when Secretary Charlie’s bulk order of Pfizer vaccines arrive, they can be used on children 12 to 15 years old),” said Domingo

Sinopharm EUA application update

In a related development, Domingo said that the Department of Health (DOH) already filed last May 20  an application for EUA for the COVID-19 vaccine developed by China-based drug maker Sinopharm. 

“Patapos na rin po yung evaluation ng mga experts natin sa data na nakuha natin and it seems to be very favorable (The evaluation of our experts on the data that we obtained will soon be finished and it seems to be very favorable),” he said. 

“Meron na lang pong kaunting documents na isa-submit ang DOH sa atin (The DOH only needs to submit a few more documents to us) and we believe that we will be able to also complete the evaluation and issue an EUA for Sinopharm, either towards the end of this week or early next week,” he added. 

In a statement last May 7, the World Health Organization (WHO) said it “listed the Sinopharm COVID-19 vaccine for emergency use, giving the green light for this vaccine to be rolled out globally.”

“On the basis of all available evidence, WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy for symptomatic and hospitalized disease was estimated to be 79 percent, all age groups combined,” the WHO said. 

SOURCE: https://mb.com.ph/2021/05/27/ph-fda-to-soon-clear-pfizer-covid-19-vaccine-for-those-aged-12-to-15-yrs-old/